A phase I/II study of recombinant human interleukin-12 in patients with chronic hepatitis B

Background/Aims: Interleukin-12 (IL-12) may be active against hepatitis B virus (HBV). The objective of the study was to assess the tolerability, activity, pharmacokinetics, and pharmacodynamics of three dose levels (0.03 μg/kg b.w., n=15; 0.25 μg/kg b.w., n=15; 0.50 μg/kg b.w., n=16) of recombinant...

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Bibliographic Details
Published in:Journal of hepatology 2000-02, Vol.32 (2), p.317-324
Main Authors: Carreño, Vicente, Zeuzem, Stefan, Hopf, Uwe, Marcellin, Patrick, Cooksley, W.Graham E., Fevery, Johan, Diago, Moisés, Reddy, Rajender, Peters, Marion, Rittweger, Karen, Rakhit, Ashok, Pardo, Margarita
Format: Article
Language:English
Subjects:
Adjuvants, Immunologic - administration & dosage
Adjuvants, Immunologic - adverse effects
Adjuvants, Immunologic - pharmacokinetics
Adjuvants, Immunologic - therapeutic use
Adolescent
Adult
Aged
beta 2-Microglobulin - blood
Biological and medical sciences
Chronic hepatitis B
Dose-Response Relationship, Drug
Female
Hepatitis B virus e antibody
Hepatitis B virus e antigen
Hepatitis B, Chronic - blood
Hepatitis B, Chronic - drug therapy
Humans
IL-12 pharmacodynamics
IL-12 pharmacokinetics
Immunomodulators
Interferon-gamma - blood
Interleukin (IL)-12 therapeutic use
Interleukin-10 - blood
Interleukin-12 - administration & dosage
Interleukin-12 - adverse effects
Interleukin-12 - pharmacokinetics
Interleukin-12 - therapeutic use
Male
Medical sciences
Middle Aged
Pharmacology. Drug treatments
Recombinant Proteins - administration & dosage
Recombinant Proteins - therapeutic use
Treatment Outcome
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Summary:Background/Aims: Interleukin-12 (IL-12) may be active against hepatitis B virus (HBV). The objective of the study was to assess the tolerability, activity, pharmacokinetics, and pharmacodynamics of three dose levels (0.03 μg/kg b.w., n=15; 0.25 μg/kg b.w., n=15; 0.50 μg/kg b.w., n=16) of recombinant human (rHu) IL-12 given s.c. once a week for 12 consecutive weeks. Methods: Forty-six patients with chronic hepatitis B, HBV DNA positivity and aminotransferase elevation were included in a multicenter prospective randomized phase I/II study. Results: Compared with the baseline, HBV DNA levels had decreased significantly at the end of rHuIL-12 treatment and after the 12-week follow-up period ( p
ISSN:0168-8278
1600-0641
DOI:10.1016/S0168-8278(00)80078-1